Reported Feb 16, 2022 · Terminated

APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00

ULTRAtab Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ULTRAtab Laboratories, Inc. · 50 Toc Dr · Highland, NY · 12528-1506

Is this the product you have?

  • APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
Lot codes and dates
  • Product CodesL210L
  • Bulk Lots
    • 18L120
    • 19B044
    • 19E082
Amount recalled
6,249,082 tablets

This recall covers 42 products

The agency filed one notice per product. You are reading one of them; the other 41 are below.

29 more are in the archive.

Why it was recalled

CGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 7, 2025 · Data as of Sep 19, 6:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.